InDepthNH.org - The New Hampshire Center for Public Interest . risk As I like to say, the greatest strength of VAERS is that anyone can report anything to it, but simultaneously the greatest weakness of VAERS is that anyone can report anything to it. Competing interests: The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. Indeed, Facebook posts seen by the HPR with hundreds of engagements include the same verbatim instructions, copy and pasted, for users to disregard disclaimers. As the spread of coronavirus variants potentially jeopardises the efficacy of the vaccine rollout, so too does the spread of misinformation. Based on the law of large numbers, in which very small percentages translate into a large number of actual cases or people, we would expect a lot more deaths within a couple of weeks after vaccination by random chance alone. By the sixth month post-vaccination, she was seen by a neurologist and a physiatrist. Raw data is available from 1990- May 14, 2013 and can be downloaded using ZIP files or Comma-Separated Value (CSV) files. He was treated again with Acyclovir. Human Rabies Prevention --- United States, 2008 Recommendations of the Advisory Committee on Immunization Practices NOTE: A Continuing Education Activity has been approved for this report and will be included in the print and electronic format on May 23, 2008, in Vol. However, the CDC and FDA have never required the vaccine manufacturers to publicly divulge the number of vaccines contained in a given lot. : Vaccine-associated uveitis following COVID-19 vaccination: vaccine adverse event reporting system database analysis. There is no confirmed evidence of a COVID-19 vaccine causing the death of even one child. 2023 Feb;130(2):179-186. doi: 10.1016/j.ophtha.2022.08.027. But definitely its being underreported.. The rash slowly subsided but left scars. Approximately two hours following vaccination, a transient welt developed at the injection site with a 3-inch line of lymphangitis. Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. Later in the article, CHD starts listing all the anecdotes and other reports that antivaxxers have been flogging. The site is secure. To reach such a critical mass, the federal government is in a race against time. The bottom line is that 285 deaths after COVID-19 vaccination reported to VAERS in a timeframe of 40 days is actually a very small number. Facebook and Instagram announced earlier this year they would take steps to ban the spreading of vaccine misinformation on their platforms. Am. The term underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Bookshelf So there is no way to explain the excess deaths which are effectively over 640,000 for a 41 underreporting factor. Conclusion . 2020 Jul 22;38(34):5464-5473. doi: 10.1016/j.vaccine.2020.06.038. For anaphylaxis, VAERS captured 13-27% of cases after the pneumococcal polysaccharide vaccine, 13% of cases after influenza vaccine, 21% of cases after varicella vaccine, 24% of cases after both the live attenuated zoster and quadrivalent human papillomavirus (4vHPV) vaccines, 25% of cases after the combined measles, mumps and rubella (MMR) vaccine, and 76% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine. She was admitted to a hospital for rehydration after losing 12 lbs or more than 10% of her previous healthy weight. From 2012 through 2016, vaccine providers submitted 32% of U.S. VAERS reports; vaccine manufacturers submitted 41%; patients . caused the event. First, you must understand that, as I alluded to above, VAERS isnt intended to give an accurate estimate of the frequency of various adverse events after vaccination. 2023;130: S0161-6420(22)00672-8. doi: 10.1016/j.ophtha.2022.08.027. ]Jw/d}n?`nGDzh,5crb?|IlO87m:8S.A);B9+k liSC`y2WW0Z=+'kv$n6I,%AMe13em1e63?d[@f=PaVkAV{2"CeU(H3'S?V;5U n3`(*9u&PY)Ug*Q&ObFMRY;Leq,*]&kIegxKw) h_2YQ)HGA&[?/f4Fkk;k&5#{@5d5KM=I&In'$v:j\C5sft4 2] 5 ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. Thats 40 days, if you count December 14, 2020. so wed expect 96/100,000 deaths during that period. Zh. National Center for Complementary and Integrative Health, Steven P. Novella, MD Founder and Executive Editor, David H. Gorski, MD, PhD Managing Editor, unnecessary because COVID-19 is not deadly, 329 Deaths + 9,516 Other Injuries Reported Following COVID Vaccine, Latest CDC Data Show, Mark and David Geiers epically bad study, similar back-of-the-envelope calculations, Excess mortality during the pandemic has been VERY high, falling for an antivaccine conspiracy theory, against public health and any collective action, surgical oncologist at the Barbara Ann Karmanos Cancer Institute, American College of Surgeons Committee on Cancer Liaison Physician, Melanoma: A Pseudoepidemic of Skin Cancer Prompts New Screening Recommendations. Her CPK was elevated to 676. It would be a dramatic improvement over the current health-care-worker-initiated reports. VAERS accepts all reports of suspected adverse events, in all age groups. So lets get back to RFK Jr. and his deceptive article by the Childrens Health Defense Team. I know that this discussion began with The point of Harvard Pilgram Health Care, Inc. getting that grant was to develop a much more efficient system for capturing vaccine injuries, a system that would be built into electronic health records systems and so could flag temporal relationships between vaccinations being dispensed and symptoms subsequently reported. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. VAERS is a passive surveillance system that relies on the willingness of individuals and professionals to submit reports voluntarily. 15. She and other immune employees were recruited as healthy controls for a manufacturer-sponsored vaccine study aimed at detecting the boosting effect of the vaccine. With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. This prevents researchers from determining "hot lots" since calculation of the number of adverse reactions per lot is not possible. Covid-19 was the eighth leading cause of death among children in recent months, according to a study published Monday. Vaccine (1999) 17(4):327-329. So were there any problems with meeting the objectives of the grant? EMRs available from all ambulatory care encounters in a large multi-specialty practice were used. providers, patients, or family members. Pediatr Infect Dis J 29:483, 2010) Even for infants 3-6 While the VAERS database numbers are sobering, according to a U.S. Department of Health and Human Services study, the actual number of adverse events is likely significantly higher. I assume the claim from Kirsch is based on a 10 year old report from Harvard-Pilgrim insurance showing that only ~1% of drug related adverse effects are reported. 20.8 per 100,000 person-years. understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. Whats 285 divided by 22 million? The first is: Whats the denominator? Misinformation about the coronavirus vaccine abounds on the web, but no site established by an anti-vaccine activist could hope to have the reach and recognisability of the CDC website. In the time since the CDC was approached for comment by the HPR, the shareable buttons have been removed from the site. Mercolas reference #7 is superfluous, because it also references #6. Indeed, antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. VAERS cannot determine if a vaccine was the specific cause of an adverse event. consequently the incidence rate reported to VAERS was 0.10 KD cases per MeSH Epub 2022 Aug 31. The CDC blocked both the data collection by the Harvard Pilgrim group, and also any implementation that could have followed from their findings. Consider this part 2 of my post from two weeks ago, the VAERS edition. Its not just vaccines and autism, either. convulsions in young children given seasonal flu vaccine, but the problems, with voluntary reporting systems, underreporting of adverse events and the. An EMG revealed involvement in an ulnar distribution. 9. Unsurprisingly, RFK Jr. fails to mention that the BMJ article to which he refers is a BMJ Rapid Response, which is basically a comment section that is not peer-reviewed that cranks love to use to post their ramblings and then cite them as though they were legitimate articles in The BMJ. The individual's susceptibility is determined by the genetic background and previous immunological history. That claim is based on an old study about drug reactions and was not specific to vaccines. Some infants will experience these medical events shortly after a vaccination by coincidence. How There is no citation for that sentence. 2023 Jan 4:S0161-6420(22)00929-0. doi: 10.1016/j.ophtha.2022.11.023. Source information from U.S. Government VAERS data base, 1990-2003, http://www.medalerts.org/vaersdb The Vaccine Adverse Event Reporting System (VAERS) is a valuable tool for post-marketing safety surveillance (monitoring after a product has been approved and is on the market). It is the Vaccine Adverse Event Reporting System, commonly known as VAERS. The database makes for gruesome reading, with side-effects of the vaccine appearing to include brain death, herpes and even one case of a gunshot wound. First, the denominator, which CHD provides without using it appropriately: According to the Washington Post, as of Jan. 29, 22 million people in the U.S. had received one or both doses of a COVID vaccine. But thats Norway. What about the US and VAERS? (Pediatr Infect Dis J 28:943, 2009) From 1988 to COVID-19 Vaccines and Myopericarditis: A Nuanced Story. Again, these are back-of-the-envelope calculations, but theyre close enough to make the point. It was the waiting that drew the attention of the Stockholm County Council. vaccine-caused illness? Reports vary in quality and completeness. (Pediatr Infect Dis J 28:943, 2009. Similarly, as expected, antivaxxers point to anecdotes of bad things happening to people after receiving the vaccine that are almost certainly coincidences and not related to the vaccine and are weaponizing them to spread fear. Published online ahead of print). Whos Really Responsible for Climate Change? Cost-benefit analyses of varicella vaccination appear optimistic, but they fail to factor in the resulting deleterious effects. Am. Twenty-eight months following varicella vaccination (October 29, 2002), he developed breakthrough chickenpox with an estimated 30 to 40 lesions that were intensely itchy. VAERS (Vaccine Adverse Events Reporting System) is the voluntary system used in the U.S. to signal vaccine side effects. Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis. Then they invoke the deaths in nursing homes in Norway gambit. No competing interests, Medical Veritas International (MVI), P.O. He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. We used data from VAERS safety reviews as the numerator, and estimated incidence rates of anaphylaxis and GBS following vaccination from the Vaccine Safety Datalink (VSD) studies as the denominator. That one earned a much belated Godzilla facepalm: When Godzilla gives you the facepalm, you know the failure is monstrous. J. According to the VAERS data, of the 329 reported deaths, 285 were from the U.S., and 44 were from other countries. A Harvard Vaccine Injury Study conducted from 2007 to 2010, reveals on page 6 a fewer than 1 % report rate in VAERS. to More than 485 million doses of COVID-19 vaccines were administered in the United States from Dec. 14, 2020 . way the data are used by public health officials and the vaccine industry Her physician was of the opinion that a virus probably triggered her autoimmune response. 2, 3 Reasons for clinician under-reporting might include failure to associate an acute health event to recent vaccines, lack of awareness of VAERS, the misperception that only serious events should be reported, or lack of At the end of the document is not a list of supporting citations, but only a list of publications by the organization on the topic of the automated adverse event reporting. VAERS (Vaccine Adverse Events Reporting System) is (1986) 8(1):78-80. It is a reference to substantiate claims that the CDC has no interest in making reports of vaccine injury either more accurate or more comprehensive. These statistics are, of course, patently false. The point of the grant given was to develop a more accurate system for capturing vaccine injuries, one that mined electronic medical records in real time, generating flags and reports for physician approval of automated submission to VAERS. If anyone can find one or several citations that actually seek to quantify VAERS underreporting, please send me a note. With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock.